Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004184

Trial Description

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Title

Influence of a rehabilitative exercise program on physical, psychological and psychosocial parameters in prostate cancer patients

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Trial Acronym

ProRehab Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to examine the influence of physical activity on physical, psychological and psychosocial parameters in prostate cancer patients following a prostatectomy or combination treatment (prostatectomy + radiotherapy). The main aim is to demonstrate whether a 15-month rehabilitative exercise program has a positive influence on the physical fitness of prostate cancer patients. The aim is to include 200 patients in the study that comply with the inclusion and exclusion criteria.

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Brief Summary in Scientific Language

In this non-randomized controlled trial the aim is to evaluate the effects of a multi-modal exercise program which is offered to prostate cancer patients in newly founded rehabilitative sports groups. While patients in the intervention group will exercise in a rehabilitative sports group for 15 months, patients in the control group will not take part in the exercise intervention. The main outcomes of the study include physical fitness, urinary incontinence, erectile dysfunction, quality of life, physical activity levels and prostate cancer related blood parameters.

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Organizational Data

  •   DRKS00004184
  •   2012/07/03
  •   [---]*
  •   yes
  •   Approved
  •   16/2007, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   15 month exercise program within a rehabilitative sports group
  •   no intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

The primary endpoint is physical fitness, assessed with a spiroergometry on a treadmill at baseline, after 6 months and after in the intervention

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Secondary Outcome

Secondary endpoints are urinary incontinence measured with the 20-Min. Pad-Test at three assessment time points; erectile dysfunction assessed with the IIEF questionnaire at five assessment time points; testosterone, PSA, endostatin, VEGF and IL-6 assessed by taking blood samples at three measurements; general quality of life and prostate cancer-specific quality of life assessed with the EORTC-QLQ-C30 and EORTC-QLQ-PR25 questionnaire at five assessment time points; physical activity levels (MET score) assessed with the Freiburger questionnaire of Physical Activity at five assessment time points; adherence evaluated by an adherence questionnaire at five assessment time points.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2008/02/13
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with a prostate cancer disease who completed primary treatment; patients who underwent a radical prostatectomy or combination therapy (radical prostectomy + radiation); Patients who completed their primary treatment no longer than 6 to 12 weeks before the intervention begins; written consent

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Exclusion Criteria

severe cardiac disease (NYHA III-IV); severe mental illness or chronic disease that rules out regular physical activities; (neo-)adjuvant chemotherapy; hormone therapy; irradiation without radical prostatectomy; regular physical activities of more than 60 minutes per week; current alcohol, drug, or medication abuse; insufficient german language skills

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Krebsgesellschaft Nordrhein-Westfalen
    • Volmerswerther Str. 20
    • 40221  Düsseldorf
    • Germany
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    •   0211/15760995
    •   [---]*
    •   [---]*
    •   [---]*
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    • LandesSportBund Nordrhein-Westfalen e.V.
    • Friedrich-Alfred-Str. 25
    • 47055  Duisburg
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Barmer GEK
    • Lichtscheider Straße 89
    • 42285  Wuppertal
    • Germany
    end of 1:1-Block address other
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin Abt. Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin Abt. Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Krebsgesellschaft Nordrhein-Westfalen
    • Volmerswerther Str. 20
    • 40221  Düsseldorf
    • Germany
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    •   0211/15760995
    •   [---]*
    •   [---]*
    •   [---]*
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    • Barmer GEK
    • Lichtscheider Straße 89
    • 42285  Wuppertal
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/21
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.